FDA Establishment Identifier (FEI) Number
Frequently Asked Questions (FAQ) for domestic and foreign establishments
What is an FDA Establishment Identifier (FEI)?
An FDA Establishment Identifier (FEI) is a unique, system‑generated number assigned by the U.S. Food and Drug Administration (FDA) to identify a specific firm, establishment, or physical site involved in FDA‑regulated activities. It is used across multiple FDA centers and programs to consistently track that facility in inspection records, registration databases, adverse‑event systems, and enforcement actions. The FEI acts as a “master key” identifier that links together a facility’s regulatory history over time and across different product types (drugs, devices, food, cosmetics).
2. Who assigns the FEI?
The FEI is assigned by the FDA’s internal identification system, typically when a facility registers or is otherwise entered into one of the FDA’s program databases (for example, drug‑establishment registration, device establishment registration, or food facility registration). No separate application for an FEI exists. The number is generated automatically by FDA systems when the facility’s information is processed. FDA program staff may also manually assign or update FEIs when they create or clean up records during inspections or compliance reviews.
3. Why was the FEI created?
The FEI was created to solve the problem of tracking facilities consistently across different FDA programs and over time. Before the FEI, the same firm could appear under slightly different names or structures in separate databases, making inspections, recalls, and compliance follow‑up harder. By assigning one unique FEI per distinct establishment, the FDA can reliably link registrations, inspections, warning letters, and product events to the correct facility, improving transparency and regulatory efficiency.
4. Which types of facilities can receive an FEI?
Any facility that manufactures, tests, packs, labels, relabels, or distributes FDA‑regulated products may receive an FEI. This includes, for example, drug manufacturing sites, medical‑device production and sterilization facilities, food processing plants, dietary‑supplement manufacturers, biologics facilities, and cosmetic‑product manufacturing or packing sites. Whether or not an FEI is ultimately assigned depends on whether the facility is registered or otherwise entered into an FDA tracking system for those activities.
5. Is having an FEI mandatory?
The FEI itself is not granted by a standalone legal requirement; instead, it is a consequence of engaging in FDA‑regulated activities that require registration or reporting. For example, drug‑establishment registration, device establishment registration, and certain food and cosmetic‑facility registration programs require facilities to provide information that triggers FEI assignment. In practice, most facilities that must register with the FDA will obtain an FEI, even though the statute does not say “obtain an FEI number” explicitly.
6. How long is an FEI Number?
An FEI is typically a numeric identifier that is 7 to 10 digits long. The exact length is determined by the FDA’s internal numbering system, and the number is not calculated from other business identifiers (like tax IDs or DUNS numbers). Because the format is proprietary to FDA systems, facilities usually receive the FEI as a fixed string and use it as‑provided in all regulatory communications and submissions.
7. Do I need an FEI for each physical location?
Yes. In general, each distinct physical location that performs FDA‑regulated activities should have its own FEI. For example, if a company operates three separate manufacturing plants in different cities, each plant is typically treated as a separate establishment and receives its own FEI. Exceptions can occur if FDA consolidates records or if two sites are treated as a single integrated operation under one regulatory entry, but this is determined by the FDA on a case‑by‑case basis.
8. Can one company have multiple FEIs?
Yes, a single legal company can have multiple FEIs if it operates multiple physical establishments or sites that are each registered or tracked separately by the FDA. For instance, a multinational corporation may have one FEI for its U.S. drug‑manufacturing site, another for its medical‑device plant, and additional FEIs for foreign facilities that manufacture or export products to the United States. Each FEI reflects a specific site, not the entire corporate entity.
9. How is an FEI different from a DUNS or EIN?
A DUNS (Dun & Bradstreet) number identifies a business entity in commercial and credit databases, while an EIN (Employer Identification Number) is a tax‑payer identifier issued by the IRS. Both are general business identifiers used outside of FDA regulation. In contrast, an FEI is an FDA‑specific identifier for a facility performing FDA‑regulated activities and is used primarily within FDA systems for inspections, registrations, and enforcement, not for general commercial or tax purposes.
10. How is an FEI different from a food facility registration number?
Under the Bioterrorism Act and related food‑facility registration rules, each U.S. and foreign food facility must register with the FDA and is assigned a 11‑digit registration number. The FEI is used alongside this number to track the facility’s inspection history, recalls, and enforcement actions. In many cases the FEI and the food‑facility registration number are associated with the same physical site, but the FEI is the internal FDA‑tracking number, while the 11‑digit number is the formal registration identifier reported on registration forms.
11. How is an FEI different from a Unique Facility Identifier (UFI)?
The UFI (Unique Facility Identifier) is a non‑proprietary, standardized location code (such as a Global Location Number) that FDA may collect on registration forms to help identify the facility. The FEI, by contrast, is the proprietary, FDA‑assigned internal number that powers FDA databases and tracking. While the UFI can be used externally or across systems, the FEI is used internally by the FDA to link registrations, inspections, and product events to a specific facility.
12. How is an FEI used in drug applications?
In drug development and approval processes, the FEI is used to link drug applications (such as NDAs, ANDAs, and BLAs) to the specific manufacturing or testing sites that will produce or analyze the drug. The FDA uses this link to plan pre‑approval and routine inspections, review a site’s past compliance history, and assess whether the facility is suitable to manufacture the product. Including the correct FEI helps avoid delays caused by mis‑identified or untracked sites.
13. How is an FEI used in medical‑device submissions?
For medical devices, the FEI connects device establishment registrations and listings to the correct manufacturing or exporting facilities in FDA systems. When a device is submitted for review or clearance, the associated FEI allows the FDA to evaluate the site’s inspection history, prior 483 or warning‑letter history, and any recalls or enforcement actions. This helps the FDA determine whether the site can reliably produce the device in compliance with quality‑system requirements.
14. How is an FEI used in food‑related activities?
For food facilities, the FEI enables the FDA to track inspection history, import alerts, and recalls associated with that establishment. During food‑safety investigations or outbreaks, the FEI helps the FDA quickly pull up all records related to the facility, including past inspection findings, corrective‑action plans, and any prior regulatory actions. This speeds up response times and improves coordination with the facility during a public‑health incident.
15. How is an FEI used with cosmetics?
Under the Modernization of Cosmetics Regulation Act (MoCRA) and the new cosmetics facility registration and product listing system, the FDA intends to use the FEI as the required facility registration number. When a cosmetic‑facility owner registers, the FEI will link that facility to the products it produces or processes, allowing the FDA to trace cosmetic products back to their manufacturing sites in the event of recalls, adverse events, or safety investigations.
16. How can I look up an FEI?
You can look up an FEI using FDA‑hosted tools such as the FEI portal or the AccessData FEI search page, when those systems are publicly available. These tools typically allow searching by facility name, address, city, state, or country. Some third‑party or consulting services also provide access to FEI‑lookup interfaces, but the authoritative source remains the FDA‑run systems.
17. What information is needed to search for an FEI?
To search for an FEI, you generally need key facility details such as the legal or operating name, street address, city, state or province, and country. The more precise your information (for example, the exact street number versus a general PO box), the more likely the search will return the correct FEI if it exists in FDA systems. Some interfaces may also allow partial matches or wildcard searches, depending on the tool.
18. How do I get an FEI for my facility?
An FEI is typically obtained automatically when your facility registers with the FDA through the appropriate program. For example, when a drug‑manufacturing site completes drug‑establishment registration or when a food facility registers in the FDA’s food‑facility registration system, FDA systems generate the FEI behind the scenes. There is usually no separate “FEI application”; instead, providing complete and accurate registration data triggers automatic FEI assignment.
19. What should I do if I don’t know my FEI?
If you do not know your FEI, start by checking recent FDA correspondence (such as inspection reports, warning letters, or registration confirmations), which often list the FEI. If it is not there, use an FDA‑hosted FEI search tool and enter your facility details. If the search fails or you suspect a mismatch, contact the relevant FDA center (for example, CDER for drugs, CDRH for devices, or CFSAN for food) and ask that they confirm or provide your FEI. This is especially important before submitting new applications or responding to inspection findings.
20. What if my FEI is missing or incorrect on FDA forms?
If your FEI is missing or incorrect on an FDA registration form or application, you should correct it as soon as possible through the appropriate FDA system or by contacting the responsible FDA program. Errors or omissions can cause confusion, such as linking the facility to the wrong inspection history or delaying reviews because the FDA cannot quickly verify the site’s compliance record. Correcting the FEI early helps prevent unnecessary follow‑up questions and regulatory delays.
21. Can an FEI Number change?
Yes, in some circumstances an FEI can change. This may happen if the FDA merges multiple FEI records into one “surviving” FEI, or if a facility is restructured, merged, or re‑registered under a different structure. When an FEI is retired or changed, the FDA’s systems usually retain the old FEI in the audit trail so that historical records can still be traced back to the new identifier. However, moving forward all new records should reference the updated FEI.
22. What happens when multiple FEIs exist for one firm?
If multiple FEIs exist for one firm, the FDA may conduct a data‑cleanup exercise to consolidate those records. One FEI is typically designated as the “surviving” FEI, and the other FEIs become child or historical records linked to it. This consolidation helps ensure that the firm’s inspection history, registrations, and enforcement actions are all tied to a single, accurate identifier, reducing the risk of regulatory confusion or missed compliance issues.
23. Who should use the FEI in their communications?
Any entity that manufactures, tests, packs, labels, relabels, or distributes FDA‑regulated products should use the correct FEI when communicating with the FDA. This includes manufacturers, contract manufacturers, repackagers, distributors, and logistics or testing facilities that hold products under FDA jurisdiction. External parties such as consultants, contract research organizations, and suppliers may also need to use the FEI when acting on behalf of a registered facility in regulatory submissions or responses.
24. On which FDA forms do I need to provide the FEI?
You may be asked or required to provide the FEI on several FDA forms, including drug‑establishment registration forms, device establishment registration forms, certain inspection and enforcement forms, and increasingly on food and cosmetic‑related registration submissions. Even when not explicitly required, including the FEI on forms and attachments helps the FDA quickly locate your facility in its databases and ensures that your submissions are linked to the correct regulatory history.
25. Does every FDA‑regulated product submission require an FEI?
Not every FDA‑regulated submission explicitly requires an FEI, but submissions that reference a manufacturing or testing site benefit greatly from including it. For example, drug and device submissions that name a facility for production or analysis should reference the site’s FEI so the FDA can instantly connect the application to that site’s inspection and compliance history. The specific requirement depends on the product type and FDA center, but using the FEI is strongly recommended whenever a facility is involved.
26. Can contract manufacturers operate without an FEI?
Contract manufacturers that perform FDA‑regulated manufacturing, testing, or packaging for products shipped to the United States are generally expected to register with the FDA and be assigned an FEI. Operating without an FEI may not be explicitly illegal, but it can expose the facility and its customers to regulatory risk, including delays in drug or device approvals, failed inspections, or difficulties tracing products during recalls. For most contract manufacturers, obtaining and maintaining an FEI is a practical necessity.
27. How does the FEI affect FDA inspections?
The FEI streamlines FDA inspections by allowing inspectors and program staff to quickly look up a facility’s inspection history, prior 483s (inspectional observations), warning letters, and any past recalls or enforcement actions. This historical context helps the inspector tailor the inspection scope, allocate more time to high‑risk areas, and verify that previously identified issues have been corrected. A missing or wrong FEI can lead to delays or confusion during the inspection process.
28. How does the FEI relate to recalls and enforcement?
In recalls and enforcement actions, the FEI is used to link the incident to the correct manufacturing or distribution facility and its regulatory history. When a recall is initiated, the FDA can pull up all past issues at that FEI, assess whether this is a recurring problem, and determine appropriate follow‑up actions. Similarly, warning letters and other enforcement documents are associated with the FEI so that future reviewers can see the full pattern of compliance or non‑compliance at that site.
29. Should I include the FEI on product labels?
No, the FEI is not typically required or recommended on product labels for consumer or commercial use. The FEI is an internal FDA tracking number used primarily in regulatory databases and communications, not a product‑ or consumer‑facing identifier. Product labels generally use different codes such as lot numbers, barcode identifiers, or unique device identifiers (UDIs), as required by the applicable regulations, rather than the FEI.
30. Do foreign facilities need an FEI?
Yes, foreign facilities that manufacture, test, pack, or distribute FDA‑regulated products destined for the U.S. market are generally required to register with the FDA and are therefore assigned an FEI when they are entered into FDA systems. This allows the FDA to track inspections, import alerts, and enforcement actions for overseas sites just as it does for domestic facilities. Failure to register or provide accurate information can lead to delays or refusals at the U.S. border.